Pharmacy Commission SBAR · USP compounding standards. Non-resident pharmacies account for almost 40% of pharmacies licensed by the Commission. A non-resident pharmacy must provide

Commission SBAR Communication

DOH XXX-XXX

Agenda Item/Title: Pharmacy Commission Legislative Stakeholder meeting

Date SBAR Communication Prepared: December 7, 2018

Reviewer: Steven Saxe, Executive Director

Link to Action Plan:

Action Information Follow-up Report only

Situation: (Briefly describe the current situation. Give a clear, succinct overview of pertinent issues)

The Pharmacy Commission has two request legislation bill for the 2019 session and two potential bills for the 2020

session or later. We want to continue to collect stakeholder input prior to the beginning of the session in January.

In addition, the Opioid Response Workgroup had two items that they asked the Pharmacy Commission to facilitate

the collection of stakeholder input.

Background: (Briefly state the pertinent history): The Pharmacy is requesting approval for two separate bill in the 2019 legislative session. The Commission wanted

to continue to receive input as these bills are finalized.

Increase the efficiency of the electronic prescribing approval process and clarifying responsibility for

confidentiality process and procedures – 2019 Leg Session

Amend RCW 18.64.360 to allow the Commission to require nonresident pharmacies to submit

inspection reports from a commission-recognized inspection program. – 2019 Leg Session

The Pharmacy Commission is continuing to collect input for the following two bills for consideration in

the 2020 or later legislative sessions.

Update the grounds and process for discipline and enforcement of entity licenses under chapter 18.64

RCW. 2020+ Leg Session

Omnibus Pharmacy Practice Act Update

Washington State Opioid Response Plan – Goal 1 / Strategy 6. The following two items were identified in

the Washington State Opioid Response Plan. The Statewide Workgroup asked the pharmacy commission

to take the lead in trying to collect stakeholder input. This input will help determine if additional

legislative action should be taken and if so, what recommendations should be considered.

Engaging stakeholders to discuss potential new policies to eliminate paper prescriptions.

Develop criteria for when opioid distributors should report suspicious orders.

Assessment: (Summarize the facts and give your best assessment. What is going on? Use your best

judgment) Attached are documents with brief summary of the meeting. Commission members of the subcommittee that

participated included; Steven Anderson, Teri Ferreira, Kat Khachatourian, Sepi Soleimanpour, and Jerrie Allard.

The subcommittee will report on the November 6 meeting.

Recommendation: (What actions are you asking the commission to take? What do you want to happen

next?

Work with the Department to support the two 2019 Request legislation bills.

Continue stakeholder work on the four remaining potential bills.

For the two items requested from the Opioid Response workgroup provide a report back on

findings.

Commission SBAR Communication

DOH XXX-XXX

Follow-up Action: (Next Steps After the meeting – Document the commission’s decision and/or any

additional steps or follow-up requested; such as, report back in 6- months, etc.)

Page 1

Pharmacy Quality Assurance Commission

Legislative Stakeholder Input

Background / Discussion Document and Stakeholder Input

November 6, 2018

The goal of this meeting is to obtain stakeholder input on the following six potential legislative

items. While are encouraging input of staff, commissioners and especially the stakeholders. For

the last two items related to the Opioid Response Plan we will want to collect this input and

provide it to the Statewide Opioid Response Workgroup. To help stimulate discussion, the

following summary of the items and potential discussion points are identified. These are not

intended to be an exclusive list of items but a conversation starter.

Increase the efficiency of the electronic prescribing approval process and clarifying

responsibility for confidentiality process and procedures – 2019 Leg Session

Legislation in 1998 provided for the electronic communication of prescription information.

RCW 69.41.055 and RCW 69.50.312.

The statues required the commission to approve all electronic prescription transmission and

receiving systems.

Commission’s expertise resides more in the practice standards and standards for a legitimate

prescription and what it should contain.

Now there are federal entities which set standards for system requirements, security and

patient confidentiality. These include:

o Office of the National Coordinator for Health Information Technology (ONC),

o the US DHHS,

o the National Institute of Standards and Technology (NIST),

o CMS, and

o DEA

Currently the pharmacist in charge is responsible for establishing and verifying policies and

procedures.

Proposal moves the responsibility to the pharmacy entity since many information systems

cover many corporate licensees.

Benefits:

o Ease regulatory burden on licensees and vendors.

o Reduce redundant regulatory requirements

o Provide greater access to electronic prescription or electronic health systems.

Discussion Items:

Any supporting comments or examples to share with the commission or department

policy staff?

Any concerns that need to be considered in developing this proposed language?

Comments Received (Note – this is not consensus but shared comments):

Should support innovation.

Support not put accountability on PIC but pharmacy since often corporate driven

systems.

Page 2

Support the idea of adding to the opioid bill if an option.

Support since estimate more than 50% not approved or do not indicate approval on Rx.

Often part of other systems.

Amend RCW 18.64.360 to allow the Commission to require nonresident pharmacies to

submit inspection reports from a commission-recognized inspection program. – 2019 Leg

Session

Nonresident pharmacies would be required to provide a satisfactory inspection report that is

substantially equivalent to the inspections required of in-state licensed pharmacies.

Substantially equivalent would include other sate inspections and programs that inspect to the

USP compounding standards.

Non-resident pharmacies account for almost 40% of pharmacies licensed by the Commission.

A non-resident pharmacy must provide an inspection report on initial licensing. However:

Some states do not inspect pharmacies regularly, or do so only based on a complaint.

Some states have lower regulatory standards, including sterile and non-sterile compounding.

This would ensure nonresident pharmacies are held to the same standard as resident

pharmacies.

Benefits include:

o Inspections by recognized third-party entities may provide assure that nonresident

pharmacies are compliant with important health and safety standards.

o Promote health and safety by requiring nonresident pharmacies meet similar

requirement as instate pharmacies.

o Additional assure to WA residents of the quality of the pharmacy services they

receive.

Discussion Items:

Any supporting comments or examples to share with the commission or department

policy staff?

Any concerns that need to be considered in developing this proposed language?

Require non-resident pharmacy to report discipline.


Cannot inspect other states. Some other states inspect every 18 months so push instate

every year.

Support. Supports safety. Concerned with trends to mail order and different standards.

Some states have no training requirement for technicians. Growing specialty pharmacies

and question level of requirements.

Pharmacies practice at different levels. Migrant pharmacies that move around. Discount

coupon programs that may not really have a pharmacy tied to them. Need to address how

to “touch” all pharmacies.

Update the grounds and process for discipline and enforcement of entity licenses under

chapter 18.64 RCW. 2020+ Leg Session

Page 3

This change will improve the disciplinary process followed by the Commission and allow for

the proper follow-up and correction of public safety concerns and violations.

The Commission has limited disciplinary actions it can take on an entity licensed under

chapter 18.64 RCW. These include denial of a license, suspension, or revocation.

When the Commission begins the disciplinary process against a pharmacist for non-

compliance of the pharmacy, the pharmacist can and have left those pharmacies leaving no

recourse for the Commission or ability to follow through on the disciplinary action. If the

pharmacist is no longer the person in charge they can no longer be held accountable for the

actions taking place within the pharmacy.

Listing the grounds for discipline and the enforcement in one section of chapter 18.64 RCW

will help our licensees know where exactly to look for these standards, rather than having

multiple sections to deal with.

Allowing the Commission to use the UDA as the disciplinary framework for sanctions and

enforcement process would give the Commission more tools in disciplinary cases involving

entities they license.

This change may increase the pool of qualified pharmacists willing to assume the

pharmacist-in-charge position because they will only be held accountable for their personal

compliance violations not system deficiencies

Discussion Items:

What are the benefits of changing the pharmacy discipline statute?

What are the concerns of changing the pharmacy discipline statute?

What types of changes should be considered in any statutory change?


Need options besides a sledgehammer.

Tools such as probation versus Close or Suspend.

Need Fining authority

Would be able to align pharmacy enforcement with other facility enforcement

Use the Statement of Deficiency / Plan of Correction model – Including Directed Plan of

Correction (though directed POC not 1st action).

Use a panel with a health law judge

The Uniform Disciplinary Act is not facility friendly to use. Not clear or good fit for

facilities. Not direct fit.

CMS uses the SOD / POC model.

Should be budget neutral (evaluate any change for budget impact)

Fines – small more frequent or larger and reserved for major issues?

Omnibus Pharmacy Practice Act Update

As the Pharmacy Commission has been working on the Rule Rewrite project, some laws have

been identified that might need to be considered for change. The Rule Rewrite is trying to make

the rules more outcome based, provide the appropriate guardrails for patient safety, yet still

flexible enough allow for emerging technology or changes in care delivery models that support

efficient but also safe patient care. The Commission has asked staff to develop a more structured

Page 4

action plan to move forward with this process. This stakeholder meeting provided an opportunity

to continue some discussions started at past commission meetings or rule workshops. Attached

is a grid of some statutes that might be considered for change. We would like to gather

stakeholder input on these or additional changes that should be considered.

Discussion Items:

Given the attached grid of potential changes, what are the pros? Cons? Concerns?

Are there additional items that should be included in the list for changes?

What are the priorities of these changes?


See Chart

Washington State Opioid Response Plan – Goal 1 / Strategy 6. The following two items were

identified in the Washington State Opioid Response Plan. The Statewide Workgroup asked the

pharmacy commission to take the lead in trying to collect stakeholder input. This input will help

determine if additional legislative action should be taken and if so, what recommendations

should be considered.

Engaging stakeholders to discuss potential new policies to eliminate paper prescriptions.

Electronic prescribing is the computer-based electronic generation, transmission, and

dispensing of a prescription.

This replaces paper, faxed and telephoned prescriptions.

This could include electronic transmission of renewal requests

Discussion Items:

What are the benefits of electronic prescribing?

What are the concerns of electronic prescribing?

What requirements or incentives should be considered around electronic prescribing?

What exceptions should be considered for electronic prescribing?


Eliminate forged prescriptions

Eliminate paper records

Decrease verification time and issues

Decrease prescriber non-compliance / DEA, etc

Decrease need for tamper resistant paper

Decrease doctor shopping

Increase time for patient care

Decrease the number of Controlled Substances prescriptions.

Support CMS meaningful use.

New Federal Opioid related bill will reportedly require ePrescribing for Medicare in

near future.

Eliminate problems with handwriting and latin abbreviations

Improve the ability to interface with EMR and PMP

Page 5

CONCERNS:

Different errors can occur such as sigs, or technical errors.

Lost prescriptions from transmission errors, (such as incorrect pharmacy, etc.)

Downtime

Cost (especially to smaller prescriber groups, dentists, etc)

Difficulty prescribing compounded drugs.

The tie to PQAC verification of ePrescibing systems.

Drug Interaction fatigue (Alarm or Alert fatigue)

WSMA supports the direction of ePrescribing but is concerned if there remains a backlog

of ePrescribing system approvals (This may have been addressed with the attestation

change)

Implement too fast. NY state had 3 year implementation.

EXCEPTIONS:

On-call Prescribers

Vets without NPI

Compounded Drugs

OTC and Herbals

Out of State Pharmacies

Minimun or small number of prescriptions (NY State is 25/year)

Vet Administration

Question if institutional pharmacies – LTC, Hospital, (Eastern State Hospital),

Discharge meds.

Develop criteria for when opioid distributors should report suspicious orders.

In an effort to best track the opioid supply chain for potential areas of concern, distributors

should report suspicious orders from purchasers. Given the problem of receiving a report without

adequate context on whether it is suspicious, we are asked to help work with others to determine

if criteria can be developed to help identify if an order might be suspicious and when and how

that should be reported. This would also assist staff who often get questions around potentially

suspicious orders and when those should be reported.

Discussion Items:

What are the benefits of receiving suspicious order reports?

What are the concerns of receiving suspicious order reports?

What drugs should be included in any suspicious order reporting?

What would qualify as a suspicious order?

o Unusual size?

o Deviating from normal patterns?

o Unusual frequency?

o Others?

What information should be shared in a suspicious transaction report?

What should the distributor do if they have an order they suspect is suspicious?

Should there be a national reporting of suspicious orders? All Orders?

Page 6

Are there any existing models that might be helpful to consider in developing a

suspicious order reporting system?


BENEFIT – decrease diversion

CONCERNS:

Stop or delay legitimate requests (need notification)

Definition. Now is subjective when to report.

HDA offered to work with the Commission.

Federal opioid bill contains language

o DEA Centralized report database

o CA, OR and other states worked with distributors. State get copies of reports.

If criteria are different in each state that would be a problem.

Get national information

Consider the Chemical companies also reporting.

Pharmacy Quality Assurance Commission - Potential 2019 Legislative Request

Comprehensive Updates to Laws Affecting Pharmacy – DRAFT STAKEHOLDER

1

Citation Title Suggested Change/Topic Reasoning

Chapter 69.04 RCW

Washington's Intrastate

Commerce in Food,

Drugs, and Cosmetics

Repeal

In the 2018 legislative session the Department of Agriculture

successfully repealed and recodifies the sections of this chapter

into Ag's own chapter. Independent review by the Commission's

AAG Christopher Gerard support the repeal of this entire

chapter. The chapter is focused on intrastate commerce, and in

most cases has not been updated since 1945. The Commission

does not use the authority it has been given under this statute.

The statute is no longer necessary since the topics found in the

chapter are covered by the United State Food and Drug

Administration regulations, and the federal Food and Drug Act.

We have also heard that the House Agriculture Committee has

expressed support for repealing this chapter. We would need to

confirm.

Stakeholder Input:

New Section

Creation of new licensure category for self-service

dispensing devices – kiosks.

Technology has advanced significantly since several sections of the Pharmacy Practice Act have been updated. Kiosks, otherwise known as self-service dispensing devices, could increase access to prescriptions on college campuses, and rural areas. The Commission is currently limited in licensing these types of technology because of the definition of pharmacy and practice of pharmacy currently in statute. A new licensing category may not be necessary based on the potential changes to definitions. However, the Commission does see a need to distinguish pharmacies based on the services they provide. Stakeholder Input: Want some way to license and regulate. Consider economic extender versus access. Be forward thinking but include guardrails. Set regulations around patient safety. Consider if have or need authority for new license

category. Rule or statue? Allow PQAC to define. Allow for PQAC to set standards for dispensing

without onsite pharmacist



2

RCW 18.64.003

Commission-Meetings-

Chairperson-

Compensation and travel expenses.

Change Commission compensation to meet requirements

of RCW 43.03.265, which would increase Commission

member pay from $50 to $250.

MQAC, NCQAC, CQAC, and DQAC all have compensation references to RCW 43.03.265. Stakeholder Input: Appear that support similar compensation as other

commissions

RCW 18.64.005

Commission-Power and

Duties.

Ability to have action delegated to a panel of three

members i.e. subcommittee could take delegated action

without always have to bring it to the Commission e.g.

entity discipline; also edit to modify ALJ to HLJ.

This will help the Commission run more efficiently. Some policy and rules work would benefit from having a standing committee that can take action on behalf of the full commission when necessary. This will also help with pharmaceutical firm discipline, if other changes to the process are not moved forward through this request. It would also alleviate some confusion over the use of ALJs and HLJs for firm discipline. Stakeholder Input: See Pharmacy Entity Discipline Section.



3

RCW 18.64.011

Definitions

definition of a pharmacy, definition of compounding,

definition of practice of pharmacy, clear up on definition of

“device”; definition of manufacturer and wholesaler;

possible addition of virtual manufacturer and virtual

wholesaler.

Several definitions in RCW 18.64.011 are significantly outdated

and no longer reflect modern pharmacy practice. These

definitions also need to be updated to help the Commission in

properly structuring and delineating their licenses. Changing

definitions will also remove the circular nature of defining

pharmacy and the practice of pharmacy, these changes will allow

for more innovation and technology to be used which will result

in increased access to quality pharmaceutical care, especially in

rural areas. Stakeholder Input: Repacking Third Party Logistics (3PL) Repackager versus manufacturing 503B / Outsourcing Virtual Manufacturer / Wholesale distributor Device oversight Specialty Pharmacy

RCW 18.64.047

Itinerant vendor's or

peddler's registration—

Fee—Pena lties—

Ephedrine/pseud

oephedrine/phenylprop anolamine.

Removal of licensure of iterant vendors and peddlers.

This credential is not used frequently. However, there may still be a desire for this type of credential based on what the credential is used for, e.g. delivering meds to field workers. Stakeholder Input:

RCW 18.64.050

Duplicate for lost or

destroyed license or

certificate—Certified

documents—Fees.

Repeal

This section of RCW is no longer needed, it is covered under xxx.

RCW 18.64.160

Disciplinary action

against pharmacist's and

intern's licenses—

Grounds

Repeal - base on UDA

This subsection is redundant, all of the additional grounds are covered in some manner under the UDA. It would provide clearer direction as to how discipline is taken on personnel licenses. Additionally, RCW 18.64.163 already states the UDA will be used for pharmacist and pharmacy intern license discipline.

RCW 18.64.165

Refusal, suspension, and

revocation of other

licenses.

addition of fine authority; particularly looking at any other

sanctions but could settle for those. Look at potential UDA

language

This section is in dire need of updating. The Commission's

limited sanctions for pharmaceutical firms has been a growing

issue with the Commission, Department, and with licensees. We

have draft language that would pull firms under the UDA, but

stakeholders have expressed a desire to have a separate section for firms only, since the UDA is profession driven. Stakeholder Input: See Pharmacy Entity Discipline Section.



4

RCW 18.64.200

Refusal, suspension, and

revocation of other

licenses—Appeal procedure.

Either repeal this section in favor of having on section

speak to firm discipline and process, or amend to include

APA at all levels

Repeal would be suggested to have one section of law that addresses discipline of pharmaceutical firms. Stakeholder Input: See Pharmacy Entity Discipline Section.

RCW 18.64.250

Unlawful practices—

Penalty for violations—

Exceptions.

possible removal; first amendment issues on advertising

restriction

There is a possibility to amend or repeal this section. Penalties

and unlawful practices are generally addressed under the UDA,

so it may not be necessary to spell them out here. Additionally

restrictions on advertising present first amendment concerns. Stakeholder Input:



5

RCW 18.64.255

Authorized practices.

partial repeal to (3) as it relates to iterant vendors,

peddlers, or salespersons.

If the Commission decides to remove the iterant vendor/peddler

credential, this section would need to be updated to remove

references to same. Stakeholder Input:

RCW 18.64.270(2)

Responsibility for drug

purity—Compounding—

Adulteration—Penalty.

Amendment as it relates to compounding, but could be

marginalized by a definition change to compounding.

In addition to, in combination with, or instead of changing the definition of compounding, it would be prudent to clarify where USP standards apply. Stakeholder Input:

RCW 18.64.280

General penalty.

Repeal

This section would no longer be needed since penalties are

addressed under the UDA. This section was last updated in 1963,

before the adoption of the UDA. Stakeholder Input:

RCW 18.64.310

Department of

health—Powers and duties.

Amend section to no longer require a pharmacist to be the

Executive Director of the Commission

The Commission has begun to recognize the limitations this

requirement has had on recruitment for the Executive Director position. Stakeholder Comments: Only mentioned Oregon current ED search has Pharmacist or

Pharm Tech as preferred.

RCW 18.64.360

Nonresident

pharmacies—Definition

—Requirements—Exem

ption—Reciprocity with

Canadian pharmacies.

Amend to modifying the definition of nonresident

pharmacy to include those that do not ship, mail, deliver.

Could put additional requirements on nonresident

pharmacies.

Non-resident pharmacies now account for 40% of pharmacies

licensed in Washington, not all of these pharmacies are engaged

in mailing/shipping, but are providing workload balancing or

remote order processing services to in-state pharmacies. If a non

resident pharmacy is participating in these technologies there is

no requirement for them to be licensed in Washington. The

Commission has run into limited circumstances where tracking

an error and taking action has not been possible due to a non-

resident pharmacist being apart of the entry process but not the dispensing process. Stakeholder Input: See Non-resident inspection legislation section



6

RCW 18.64.360/370?

Nonresident

pharmacies—License

required—Application—

Renewal.

Registration for non-resident pharmacists

The Commission has discussed having a registration for nonresident pharmacists that would cost less than a Washington pharmacist license. This would allow the Commission to take action if deemed necessary. Currently the Commission has no jurisdiction of non-resident pharmacists performing functions that fall within the statutory definition of the "practice of pharmacy". If an error occurs on the front end of the prescription filling process and that is with a non-resident pharmacist not associated with a non-resident pharmacy license, the Commission has not way to take disciplinary action. Stakeholder Comments: Plus is PIC would know state rules. Con is delay to get license is staff or PIC leave. Not sure if there is significant difference in Licensing or

Registration regarding the cons.

RCW 18.64.380

Nonresident

pharmacies—

Information required—

Inspection.

Update inspection reports standards for non-resident

pharmacies

This is needed to make in-state and out-of-state pharmacies

equal in terms of inspection requirements. This will also help

ensure that non-resident pharmacies are compliant with their

state laws and rules. Current practice only requires inspection

reports to be submitted on new applications, with no requirement for follow up information to be provided. Stakeholder Input: See Non-resident inspection legislation section

ADDITIONS AT NOVEMBER 6 STAKEHOLDER

MEETING

Practice Act to allow

independent prescribing

for:

Vaccines

Naloxone

Even if there is an age limit for independent could use CDTA

for others if agreement on competence with prescriber and

pharmacist.

Practice Act to allow for

patient assessment



7

Specialty Pharmacy and

the need to consider as

part of 503B / Outsourcing



8

RCW 18.64.390

Nonresident

pharmacies—Violations

—Penalties.

Remove the language that limits the nonresident

disciplinary grounds to those statutory provisions cited.

Specifically may want to include violations of RCW 18.64 and any federal/state drug law.

This change would allow the Commission to set consistent

disciplinary actions and processes for all pharmaceutical firms

they license.

RCW 18.64A.010

Definitions.

Change definitions based on changes in RCW 18.64; Add

definition of "enrolled" and "supervision"

Any changes to definitions in RCW 18.64.011 would need to be

changed in this section for consistency. The two other

definitions noted need to be added to clarify standards for

certification for technicians who are enrolled in tech-in-training

programs. The definition of "supervision" has been a constant

hot topic in recent years with the Commission. With advances in

technology the role of technology in supervising ancillary

personnel have changed, but the law has not kept up with those changes.

RCW 18.64A.030

Rules—Duties of

technicians, assistants.

Clarify the Commission’s authority to define

nondiscretionary functions

This section needs amendments to ensure the definitions in this

section align with the definition section of this RCW. Additionally

it would be helpful to clarify the Commission's authority in

defining functions ancillary personnel can engage in.

RCW 18.64A.040

Limitations on practice.

Remove pharmacist to technician ratio, requirement for

pharmacies to have and for the Commission to approve

ancillary utilization plans; remove language our pilot

projects.

The Commission is already engaged in rulemaking to change the

standard ratio of RPhs to pharm techs to be decided by the

responsible pharmacy manager. The Commission has engaged in

research around this issue and other states who have removed

the ratio have not seen increases in discipline or affects on

patient safety. The use of ancillary utilization plans has become

outdated and boiler plate across pharmacies, the Commission

has determined they no longer need to review these plans for

approval, since pharmacies are required to know the limitations of their staff's scope of practice.

RCW 18.64A.050

Disciplinary action

against certificate or

registration—Grounds.

Repeal

This subsection is redundant, all of the additional grounds are

covered in some manner under the UDA. It would provide

clearer direction as to how discipline is taken on personnel

licenses. Additionally, RCW 18.64.055 already states the UDA will

be used for pharmacist and pharmacy intern license discipline.



9

RCW 18.64A.060

Pharmacy's application

for ancillary

personnel—Fee—

Approval or rejection by

commission—Hearing—

Appeal.

Repeal

If ancillary utilization plans are no longer required, this section

could be repealed as clean up.

RCW 18.64A.070

Persons presently acting

as technicians—

Pharmacies presently

employing those persons.

Repeal

This section is no longer needed, compliance was required within

18 months of May 28, 1977.

RCW 69.41.055

Electronic

communication of

prescription

information—Commissi

on may adopt rules—

Long-term care

facilities and hospice programs.

Remove approval of E-Rx systems

This will help the Commission run more efficiently. The

Commission no longer has the expertise to evaluate these

systems. Federal agencies already have standards that systems

must meet.

RCW 69.50.312

Electronic

communication of

prescription

information—Commissi on may adopt rules.

Remove approval of E-Rx systems

This will help the Commission run more efficiently. The

Commission no longer has the expertise to evaluate these

systems. Federal agencies already have standards that systems

must meet.

Documents

Pharmacy Commission SBAR · USP compounding standards. Non-resident pharmacies account for almost 40% of pharmacies licensed by the Commission. A non-resident pharmacy must provide